Search Results

The newly improved AIDI Dental Implant System (AIDI Fixtures and AIDI Abutments with Screws) is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaws to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved with the appropriate occlusal loading.

The improved AIDI Dental Implant System is a threaded root-form dental implant intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments (which provide cemented and screw retained restorative options), cover screws, abutment screws, and healing abutments.

The provided text is a 510(k) summary for the AIDI Dental Implant System. It describes the device, its indications for use, technical characteristics, and a nonclinical test summary, concluding with a statement of substantial equivalence. However, it does not contain information about acceptance criteria, specific device performance metrics (beyond generalized statements of "high torque strength"), or detailed study methodologies that would allow for a comprehensive answer to the requested questions.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing Information: The document does not explicitly define acceptance criteria in terms of quantitative thresholds or specific metrics. It focuses on demonstrating equivalence to predicate devices, particularly regarding "torque strength." The exact measurement or quantitative comparison of "high torque strength" is not provided.

2. Sample sized used for the test set and the data provenance

Missing Information: The document states, "The nonclinical test data of the currently submitted AIDI Dental Implant System Torque Test Report revealed high torque strength for AIDI Dental Implants." However, it does not specify:

• The sample size used for the torque test set.
• The data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing Information: This section is not applicable to the provided document. The submission pertains to a medical device (dental implant system) for which performance is assessed through nonclinical engineering tests (like torque strength), not by expert interpretation of images or other data that would require "ground truth" established by experts in a clinical context.

4. Adjudication method for the test set

Missing Information: Not applicable. As mentioned above, this is an engineering performance test, not a clinical study involving human interpretation with adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing Information: Not applicable. This document describes a dental implant system, not an AI-powered diagnostic or assistive tool that would necessitate an MRMC study or assessment of human reader improvement with AI. No clinical studies were submitted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing Information: Not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used

Missing Information: For the "Torque Test," the "ground truth" would be the measured torque strength itself, comparing the subject device to predicate devices. However, the exact methodology and quantitative results are not detailed in this summary.

8. The sample size for the training set

Missing Information: Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Missing Information: Not applicable.

Study Summary (Based on Section 4 & 6):

The device's performance was evaluated through a nonclinical Torque Test.

• Objective: To demonstrate that the AIDI Dental Implant System (current submission) possesses comparable or superior torque strength to its predicate devices.
• Methodology (limited detail): The "Torque Test Report" was submitted, which presumably details the experimental setup and measurements.
• Findings: The test "revealed high torque strength for AIDI Dental Implants (current submission)." Furthermore, the study concluded that "The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength."
• Conclusion: Based on this nonclinical testing, among other comparisons of materials, design, and technical characteristics, the manufacturer concluded that the "AIDI Dental Implant System (current submission) is substantially equivalent for its intended use and performs as well as the predicates."

In essence, the entire submission hinges on demonstrating "substantial equivalence" through nonclinical testing (specifically, a torque test) and comparison of technical characteristics, rather than establishing performance against defined acceptance criteria via comprehensive clinical studies or expert-driven evaluations.

Ask a specific question about this device

AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with AIDT Dental implant Systembents intended to be surgically placed in the Sorews) are enabose lower jaw arches to provide support for prosthetic bone of the upper of artificial tooth, in order to restore patient esthetics deviocs, suon ao an arming abutments indicated for both screw and chewing function. Straigrations are included. The implants are indicated for single or multiple unit restorations and can be used in indicator for oingle applications. The device is intended for Splinted and non opinious appress and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

AID! Dental Implant System (AIDI) is a threaded root-form dental implant intended for use (function) in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.

AIDI is an improved version of the predicated IDI Implant System (IDI). AIDI has the same scientific concepts as predicated IDI which include same internal connection design, same internal thread at apical end, same thread design at external surfaces and same surface treatment which is Soluable Blast Media (SBM).

The physical and performance characteristic of AIDI, predicated IDI and predicated NobelActive Dental Implant (NA) includes gradually expanding tapered implant body allowing for alveolar bone expanding and condensing capabilities. The material composition of AIDI and predicated IDI are Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI. AIDI is also similar to predicated NA Implants in tapered coronal design and hex-cavity internal connection design.

The provided document is a 510(k) summary for the AIDI Dental Implant System (K101755). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel technologies.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy, etc.) you would expect for a diagnostic AI device. Instead, the "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness.

The key performance attribute evaluated and reported is torque strength.

Study Information:

Given this is a 510(k) for a dental implant, the type of "studies" and "ground truth" are very different from what you would typically find for an AI medical device.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a numerical sample size. The "test set" in this context refers to the AIDI Dental Implant System components used in the nonclinical torque strength tests.
   • Data Provenance: The study was a "nonclinical test data... Torque Test Report." No country of origin is specified, and it's inherently a prospective lab test, not retrospective patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. Ground truth for torque strength testing in medical devices like implants is established through standardized engineering tests, not expert consensus.
   • Qualifications of Experts: N/A for this type of test.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Adjudication method: Not applicable. This is a physical, mechanical test, not a subjective interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No, this type of study was not done. This is a physical dental implant, not a diagnostic AI device that assists human readers.
   • Effect Size: N/A.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Standalone Study: Not applicable. This is a physical dental implant, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: The ground truth for the "torque strength" was established by mechanical testing (Torque Test Report) following presumably an established standard for dental implants.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. There is no "training set" in the context of this 510(k) submission, as it describes a physical device, not a machine learning model.

8. How the ground truth for the training set was established:

   • Ground Truth Establishment for Training Set: Not applicable, as there is no training set mentioned or implied for this device.

Overall Conclusion from the Provided Text:

The K101755 submission for the AIDI Dental Implant System is a predicate-based 510(k). The primary "study" supporting its safety and effectiveness is a nonclinical torque strength test. The "acceptance criteria" are met by demonstrating that the AIDI system exhibits a "high torque strength" that "resembles the same torque strength" as its legally marketed predicate devices (IDI™ Implant System (K081860) and NobelActive™ Internal Connection Implant (K071370)). No clinical studies or AI/software performance studies were submitted or required for this type of device. The ground truth for the single reported performance metric (torque strength) was established through objective mechanical testing.

Ask a specific question about this device